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Invasive Breast CancerNCT01340495

Proton Radiation Therapy for Invasive Breast Cancer Following Mastectomy

A study testing Proton Radiation in people with Invasive Breast Cancer, run by Massachusetts General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In this study we are looking at a type of radiation called proton radiation which is known to spare surrounding tissue and organs from radiation. The proton radiation will be delivered using 3D conformal proton radiation or scanned beam/IMPT (Intensity Modulated Proton Radiation Treatment). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Invasive Breast Cancer
What is being tested?
Proton Radiation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteUnited States
Study dates
Jun 2011to 3 Jan 2022
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed invasive breast cancer confined to the breast and regional lymphatics
  • Completed mastectomy (complete not partial )breast surgery +/- reconstructive surgery
  • Life expectancy > 12 months

Who cannot join

  • Pregnant or breast-feeding
  • Prior therapeutic radiation > 200 cGy
  • History of a different malignancy unless disease-free for at least 5 years or diagnosed and treated cervical cancer in situ, or basal or squamous cell cancer of the skin
  • Prior investigation chemotherapy

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

Other trials in United States

About this study

Official title: Pilot Study of Proton Radiation Therapy for Invasive Breast Carcinoma Following Mastectomy

In this study we are looking at a type of radiation called proton radiation which is known to spare surrounding tissue and organs from radiation. The proton radiation will be delivered using 3D conformal proton radiation or scanned beam/IMPT (Intensity Modulated Proton Radiation Treatment). Proton radiation delivers no dose beyond the region requiring treatment. This may reduce side effects that patients would normally experience with conventional radiation therapy or other means of delivering proton radiation therapy. In this study we are evaluating the effectiveness of using proton radiation delivered to reduce side effects association with radiation treatment.

Read the detailed description

Proton radiation will be delivered daily for approximately 5 1/2 weeks. Patients will be assessed weekly for any side effects they may be experiencing.

Patients will have follow-up visits 4 weeks after proton therapy ends, at 6 months, 12 months, and then every year for up to five years after treatment. Follow-up visits will include a physical examination, radiological imaging (if necessary), echocardiogram, and laboratory tests.

Being tested
Proton Radiation
Keywords
Breast Cancer, Mastectomy
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Proton RadiationRadiation

    45-50.4 Gy(RBE) to the chest wall and 45-50.5 Gy(RBE) once daily, 5 days per week, for approximately 5 1/2 weeks

Study groups in NCT01340495
Study groupRoleWhat they receive
Proton RadiationExperimentalRadiation therapy with proton beam
Receives: Radiation: Proton Radiation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Grade 3 or Higher Radiation Pneumonitis or Any Grade 4 Adverse Event

    To determine the feasibility of using proton radiation for the treatment of invasive breast cancer following mastectomy based on the occurrence of grade 3 or > radiation pneumonitis or any grade 4 adverse event within 3 months after the completion of radiation treatment.

    Measured: From the start of treatment until 3 months after the end of treatment, median duration of treatment of 6 weeks

Secondary outcomes (8)

  1. The Number of Participants With Acute Skin Toxicities

    Summary of the number of participants with any grade acute skin toxicities. Acute skin toxicity was assessed from the start of treatment until 90 days after the end of treatment. Skin toxicity was assessed using Common Terminology Criteria for Adverse Events (CTCAE 4).

    Measured: From the start of treatment until 3 months after the end of treatment

  2. Rate and Severity of Radiation Pneumonitis

    The number of participants that experienced radiation pneumonitis within three months of the end of treatment. The participants that experienced radiation pneumonitis are grouped by grade. Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE 4).

    • Grade 1: Mild
    • Grade 2: Moderate
    • Grade 3: Severe
    • Grade 4: Life-Threatening
    • Grade 5: Fatal

    Measured: From the start of treatment until 3 months after the end of treatment and was not included in the analysis population.

  3. Summary of Late Skin Toxicity

    A summary of the late skin toxicities experienced by participants. The number of participants effected is shown for each toxicity experienced. Skin toxicities were assessed using Common Terminology Criteria for Adverse Events (CTCAE 4).

    Measured: From 3 months after the end of treatment up to 5 years

  4. To Evaluate Cosmetic Outcome and Patient Satisfaction With Cosmetic Outcome

    To evaluate cosmetic outcome and patient satisfaction with cosmetic outcome, see Secondary Outcome #7 for cosmetic outcomes.

    Measured: From the start of treatment until 5 years post treatment

  5. Acute and Late Toxicity of Breast Reconstruction Following Proton Radiation

    Combined summary of the acute (within 3 months of completing treatment) and late (3 months to 5 years after completion of treatment) toxicities experienced by participants thought to be related to breast reconstruction surgery following proton radiation treatment. Toxicities are assessed using Common Terminology Criteria for Adverse Events (CTCAE 4).

    Measured: From the start of treatment until 5 years post treatment

  6. The Number of Participants That Needed Unplanned Additional Surgery for Breast Reconstruction

    The number of participants that needed unplanned additional surgery for breast reconstruction post-RT.

    Measured: From the start of treatment until 5 years post treatment

  7. The Number of Participants With Early Signs of Cardiac Effects From Radiation Therapy

    The number of participant that had early signs of cardiac effects from radiation therapy as assessed using a Strain Echo-cardiogram. The data from the Echo-cardiogram was evaluated for signs of negative impacts to cardiac function as determined by the treating physician. Parameters considered in the evaluation of the echo-cardiogram by the physician included myocardial velocity, strain, strain rate, and torsion. Blood-based cardiac bio-markers pro-BNP and ultra-sensitive troponin-I were also assessed. Either a clinically meaningful change in the strain echo-cardiogram parameters or clinically meaningful elevation of the bio-markers was sufficient to be considered to have early signs of cardiac effects.

    Measured: Baseline and then 4 and 8 weeks post treatment

  8. Progression Free Survival

    Progression-free survival is defined as the duration from the start of radiation to the date of objective disease progression or death due to any cause, whichever is earlier. Disease progression is defined as the appearance of one or more new lesions.

    Measured: from the start of treatment until the time of disease progression, up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2011 (estimated)
  2. Study startJun 2011
  3. Primary completionApr 2017
  4. Study completion3 Jan 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01340495
Sponsor's protocol ID
10-205
Status last verified
Jun 2026
First submitted
20 Apr 2011
Last updated
20 Jul 2026
Data monitoring committee
Yes

Publications

  • Hassan MZO, Awadalla M, Tan TC, Scherrer-Crosbie M, Bakar RB, Drobni ZD, Zarif A, Gilman HK, Supraja S, Nikolaidou S, Zhang L, Zlotoff DA, Hickey SB, Patel SA, Januzzi JL, Keane F, Passeri JJ, Neilan TG, MacDonald SM, Jimenez RB. Serial Measurement of Global Longitudinal Strain Among Women With Breast Cancer Treated With Proton Radiation Therapy: A Prospective Trial for 70 Patients. Int J Radiat Oncol Biol Phys. 2023 Feb 1;115(2):398-406. doi: 10.1016/j.ijrobp.2022.08.036. Epub 2022 Aug 24.

    PubMed 36028065

  • Jimenez RB, Hickey S, DePauw N, Yeap BY, Batin E, Gadd MA, Specht M, Isakoff SJ, Smith BL, Liao EC, Colwell AS, Ho A, Januzzi JL, Passeri J, Neilan TG, Taghian AG, Lu HM, MacDonald SM. Phase II Study of Proton Beam Radiation Therapy for Patients With Breast Cancer Requiring Regional Nodal Irradiation. J Clin Oncol. 2019 Oct 20;37(30):2778-2785. doi: 10.1200/JCO.18.02366. Epub 2019 Aug 26.

    PubMed 31449469

Questions about this trial

What is this clinical trial studying?

A study testing Proton Radiation in people with Invasive Breast Cancer, run by Massachusetts General Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Grade 3 or Higher Radiation Pneumonitis or Any Grade 4 Adverse Event (time frame: From the start of treatment until 3 months after the end of treatment, median duration of treatment of 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01340495, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.

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